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Clinical Trials

EyeGate’s ocular bandage gel demonstrates positive effect in pilot trial

PBR Staff Writer Published 31 January 2017

The first-in-human pilot study evaluating EyeGate Pharmaceuticals’ EyeGate Ocular Bandage Gel (OBG) has yielded positive results.

EyeGate OBG is being developed to accelerate re-epithelialization of large corneal epithelial defects

Following the findings from the results, EyeGate intends to further develop the gel with a double-masked controlled study that will evaluate its monotherapy against Bandage Contact Lens (BCL) in the second quarter of the year.

A clear viscous hydrogel eye drop having a 0.75% CMHA-S hydrogel concentrate, EyeGate OBG is claimed to can coat the ocular surface with marginal to zero optical blur. It has been designed to be degradation resistant to conditions present in the eye.

EyeGate chief medical officer Barbara Wirostko M.D. said: “Corneal epithelial defects represent a large, underserved market with no approved eye drops available in the United States for accelerating corneal re-epithelization. Such defects can lead to ocular infections, inflammation, corneal neovascularization, and vision loss if not treated promptly and effectively.

“The positive results from this pilot study of Eyegate OBG reinforces our belief in the product’s potential as a viable option for the treatment of corneal epithelial defects. We are highly encouraged by the data and remain committed to further exploring EyeGate OBG in future clinical trials.”

As per EyeGate, the bandage on the ocular surface has a prolonged resistance time which is deemed to cover the limitations of the presently available non-cross-linked hyaluronic acid formulations.

Its human trial was carried out in patients who had photorefractive keratectomy (PRK). The trial had enrolled 39 subjects who were randomized in three groups to evaluate the safety and performance of EyeGate OBG as a monotherapy or in combination with a BCL, in comparison to the present standard of care, artificial tears and BCL.

Primary endpoint of the trial was complete wound closure by the third day of the program.

Overall, the trial demonstrated safety and tolerability of OBG giving encouraging potential efficacy data as per the American pharma.